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Study on the Use of 18F-PI-2620 for Patients with Progressive Supranuclear Palsy and Parkinson's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying two neurological conditions: Progressive Supranuclear Palsy (PSP) and Parkinson's Disease. The study will use a special imaging agent called [18F]PI-2620, which is a solution for injection. This agent helps in visualizing certain proteins in the brain using a technique called PET, or Positron Emission Tomography. The purpose of the study is to analyze how this imaging agent is taken up in different regions of the brain in people with these conditions compared to those without any neurological issues.

Participants in the study will receive an injection of the [18F]PI-2620 solution. After the injection, they will undergo a PET scan, which is a type of imaging test that helps doctors see how the agent is distributed in the brain. This will help researchers understand the differences in brain activity between those with Progressive Supranuclear Palsy, Parkinson's Disease, and healthy individuals. The study will also look at how these differences relate to various factors like age, clinical symptoms, and other biological markers found in the body.

The study is expected to continue until the end of 2026, with recruitment of participants starting in mid-2024. By participating in this study, researchers hope to gain valuable insights into these neurological conditions, which could lead to better understanding and potentially improved treatments in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial consent and eligibility
Upon joining the study, the first step involves providing informed consent. This means agreeing to participate in the study after understanding all the details and implications. If unable to provide consent personally, a legal representative may do so.
Eligibility is confirmed by ensuring participants are between 40 and 80 years old, can comply with study protocols, and meet specific health criteria. Women must be postmenopausal or have a negative pregnancy test, and all participants of childbearing age must agree to use effective contraceptive methods or practice abstinence during the study and for one month after the PET scan.
Step 2
Initial health assessment
A magnetic resonance imaging (MRI) scan of the brain is conducted to rule out other neurological conditions. This is a non-invasive procedure that provides detailed images of the brain.
Participants are categorized based on their health status: those with a diagnosis suggestive of progressive supranuclear palsy (soPSP), those with probable PSP, those with Parkinson's disease, and healthy controls without neurological conditions.
Step 3
Administration of the study medication
The study involves the administration of a medication called [18F]PI-2620. This is a solution injected into the body to help visualize certain proteins in the brain using a PET scan.
The medication is administered as an injectable solution, and the dosage and frequency are determined by the study protocol.
Step 4
PET scan procedure
After the administration of [18F]PI-2620, a positron emission tomography (PET) scan is performed. This imaging test helps to visualize the uptake of the medication in the brain, providing important information about the presence of certain proteins.
The primary goal is to measure the uptake of the medication in different regions of the brain, which is quantified using a method called the standard uptake value ratio (SUVR).
Step 5
Follow-up and data collection
After the PET scan, follow-up assessments may be conducted to gather additional data. This includes monitoring any changes in health status and collecting information on demographics, clinical variables, and biomarkers from cerebrospinal fluid (CSF).
The study aims to analyze the association between the uptake of [18F]PI-2620 and these variables to better understand the condition being studied.

Who can join the trial?

8 criteria

Patients of both sexes aged between 40 and 80 years.
The subject must be able to comply with the protocols and procedures necessary for the development of the clinical trial.
Consent of the subject or his/her legal representative to voluntarily participate in the study by signing the informed consent.
In women, postmenopausal status (one year without menstruation without other medical causes) or negative pregnancy test. Subjects (women and male partners of participants) of childbearing age must agree to a commitment to practice sexual abstinence or use highly effective contraceptive methods (hormonal contraceptives that inhibit ovulation, IUDs, surgical sterilization) from their inclusion in the study until one month after the PET scan.
Magnetic resonance imaging (MRI) study of the brain to rule out any other type of relevant neurological pathology. MRI is a type of scan that uses magnets and radio waves to create pictures of the inside of the body.
PSP population: Have a clinical diagnosis of soPSP or probable PSP according to current diagnostic criteria.
Parkinson population: Have a clinical diagnosis of soPSP or probable PSP according to current diagnostic criteria.
Control population: Absence of clinical history of neuropsychiatric diseases.

Who cannot join the trial?

3 criteria

Patients with a diagnosis of Progressive Supranuclear Palsy (PSP) cannot participate.
Patients with a diagnosis of Parkinson's Disease cannot participate.
Individuals who are part of a vulnerable population are not eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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Verified sites

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Hospital Clinic De Barcelona
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Barcelona, Spain

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Investigated drugs

18F-PI-2620 is a special type of imaging agent used in this clinical trial. It is designed to help doctors see certain proteins in the brain that are linked to a rare neurological disease called progressive supranuclear palsy (PSP). This imaging agent is used in a scan called a PET scan, which allows doctors to look at how these proteins are distributed in the brain. By using this agent, doctors hope to better understand the differences in brain activity between people with PSP, those with Parkinson's disease, and healthy individuals. This can help in diagnosing and understanding these conditions better.

Izaflortaucipir (18F)

What is already known about the treatment

18F-PI-2620 – This medication is administered as an injection and is used in a PET scan to help visualize certain proteins in the brain. It is currently being studied in clinical trials to understand its effectiveness in diagnosing neurological conditions like progressive supranuclear palsy and Parkinson's disease. The main purpose of this medication is to help doctors see how much of a protein called tau is present in different areas of the brain, which can be important for diagnosing and understanding these diseases. At the molecular level, 18F-PI-2620 binds to tau proteins, allowing them to be seen on a PET scan. It is classified as a diagnostic radiopharmaceutical, which means it is used to help diagnose medical conditions through imaging.

Investigated diseases

Progressive supranuclear palsy
Progressive supranuclear palsy is a rare brain disorder that affects movement, control of walking, balance, speech, swallowing, vision, mood, and behavior. It is characterized by the gradual deterioration of specific areas in the brain. The disease often begins with problems in balance and walking, leading to frequent falls. As it progresses, individuals may experience stiffness, awkward movements, and difficulty with eye movements, particularly looking up or down. Speech and swallowing difficulties can also develop over time. The condition is associated with the accumulation of abnormal protein deposits in the brain.
Parkinson's disease
Parkinson's disease is a progressive nervous system disorder that primarily affects movement. It develops gradually, often starting with a barely noticeable tremor in just one hand. The disease is characterized by tremors, stiffness, and slowing of movement. As it progresses, individuals may experience a decrease in the ability to perform unconscious movements, such as blinking or smiling. Speech may become soft or slurred, and posture may become stooped. The condition is associated with the degeneration of dopamine-producing neurons in the brain.